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American Health Packaging

American Health Packaging Recalls

All product recalls associated with American Health Packaging.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2022

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 59 recalls

Pramipexole Tablets 0.5mg (American Health) – Cross-Contamination Risk (2019)

GMP Deviations; possible cross contamination of product due to cleaning procedure failure.

Class IIModerate

FDAMay 13, 2019Nationwide• American Health Packaging

Anastrozole Tablets (American Health) – Cross Contamination (2019)

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Class IIModerate

FDAMay 9, 2019Nationwide• American Health Packaging

Anastrozole Tablets (American Health) – Cross Contamination (2019)

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Class II

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Moderate

FDAMay 9, 2019Nationwide• American Health Packaging

GlipiZIDE Extended-release Tablets (American Health) – Dissolution Failure (2019)

Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.

Class IIModerate

FDAApr 8, 2019Nationwide• American Health Packaging

Valsartan Tablets 160mg (American Health) – CGMP Impurity (2019)

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Class IIModerate

FDAMar 6, 2019Nationwide• American Health Packaging

Aspirin Dipyridamole Capsules (American Health) – Impurity Specs (2019)

Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.

Class IIModerate

FDAMar 1, 2019Nationwide• American Health Packaging

Lovastatin Tablets USP (American Health Packaging) – CGMP Deviations (2019)

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Class IIILow

FDAFeb 19, 2019Nationwide• American Health Packaging

Nitrofurantoin Capsules (American Health) – Cross Contamination (2018)

Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."

Class IIILow

FDANov 9, 2018Nationwide• AMERICAN HEALTH PACKAGING